Introduction to Handling Data Privacy Laws and Requirements in Healthcare

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This is the 3rd blog in our healthcare series on “Data Privacy in Healthcare and the Role of Technology.” This blog series deep-dives into data privacy and transparency in the healthcare industry. It explores in detail the compliance and disclosure requirements in the global pharmaceutical industry and the international laws and regulations that guide them.

This blog series also discusses the traditional manual methods of anonymization currently prevalent, how industry 4.0 solutions can automate and vastly improve conventional anonymization, and how Gramener’s AInonymize solution can transform clinical trial disclosures and regulatory compliance in the healthcare industry.

This article further delves into the role of data privacy and confidentiality in healthcare, data privacy laws in different countries, how EMA 0070 and Health Canada PRCI balance privacy with transparency, and how anonymization tech can help.

Check out other parts of the series:

1. An Introduction to Protecting Patient Data (Part 1)
2. Data Transparency and Disclosure Requirements in Healthcare (Part 2)
3. Data Privacy Protection Techniques To Safeguard Patient Data (Part 4)

What is Data Privacy or Confidentiality in the Pharma Sphere?

Nefarious attacks against information systems and persistent cyber threats to peddle hacked data to unscrupulous bidders have recently been rising. The invasion of patient privacy is a growing concern in big data analytics, posing critical challenges to many organizations.

Data privacy allows access to information based on privacy laws and policies. This determines who can view confidential, medical, financial, and personal data and information.

Confidentiality in healthcare requires those with access to patient records to ensure that their trust is not breached or broken.

Forbes magazine reported an incident where the Target Corporation sent baby care coupons to a teenage girl, much to her parents’ surprise. To prevent such incidents, developers must ensure that their applications adhere to privacy agreements.

They also must ensure that the said sensitive information does not inadvertently become public or fall into the wrong hands because of product updates or changes in privacy regulations.

Medical data privacy is critical, and care should be taken to protect it at all costs.

Laws Around Data Privacy You Need to Know

Healthcare organizations must safeguard and manage personal information. They also must address the legal responsibilities and risks when processing personal data, ensuring that they comply with the pertinent data protection legislation.

Countries differ in their laws and policies toward data privacy. The following are some key takeaways of data protection laws and regulations enforced across countries.

Data Privacy Laws in the USA

The HIPAA Act/ Patient Safety and Quality Improvement Act (PSQIA)/ HITECH Act

• These regulations involve establishing national standards to govern electronic healthcare transactions. Individuals aged 12 and up enjoy the right to privacy.
• No healthcare-related information of any individual may be divulged, even to parents, without the said individual’s explicit consent.
• Patient Safety Work Product cannot be disclosed.
• Those who break confidentiality will face civil penalties.
• The privacy and security of electronic health information must be protected.

Data Privacy Laws in the European Union

The European Medicines Agency (EMA) Policy 0070 and the General Data Protection Regulation (GDPR)

• The EMA Policy 0070 enables academics & researchers to access precise information from the clinical study reports (CSRs) submitted to EMA by the pharmaceutical companies related to the marketing authorization applications for new medicines.
• The GDPR is the most strict security & privacy law in the world. It holds companies accountable for handling personal data, enabling consumers to gain control over their information. Violations attract harsh fines & penalties that can run into tens of millions of Euros.

Data Privacy Laws in Canada

Health Canada Public Release of Clinical Information (PRCI)

• The PRCI initiative by Health Canada makes anonymized clinical information related to medical device applications & drug submissions publicly available for non-commercial purposes. This helps Canadians make informed health decisions, encourages new research questions & facilitates re-analyses of data.

Data Privacy Laws in the United Kingdom

The Data Protection Act (DPA)

• Allows individuals to control their personal information.
• Doesn’t allow the transfer of personal data to a territory or country outside the European Economic Area unless the said region protects the individual freedoms and rights of the data subjects.

Data Privacy Laws in Russia

Federal Law on Personal Data

• Data operators must take all necessary organizational and technical measures to protect personal data against accidental or unlawful access.

Data Privacy Laws in India

IT Act and IT (Amendment) Act

• Protect sensitive personal information or data with reasonable security practices.
• A person affected by wrongful gain or wrongful loss will be compensated.
• Fine and/or imprisonment for a person who, while bound by the terms of a lawful contract to provide services, discloses the personal information of another person to cause wrongful gain or wrongful loss.

Data Privacy Laws in Brazil

Constitution

• Recognition that the image, honor, private life, and intimacy of the people are inviolable, and people possess the right against moral or material damage resulting from said violation.

How EMA 0070 And Health Canada PRCI Ask for Balance Between Privacy and Transparency

Clinical trial transparency is beneficial across the board, be it to patients, the scientific community, regulators, clinical trial sponsors, or trial participants.

Market authorization requires the disclosure of anonymized trial information. This includes clinical study document publication under Health Canada’s Public Release of Clinical Information (PRCI) and the European Medicines Agency (EMA) Policy 0070.

Reusing and sharing data brings new life to trial data, supporting health research, furthering trial transparency, and earning stakeholder trust while relieving the trial subjects’ burden. Simultaneously, if the unethical use of data erodes trust, even if you remove the identifying information of the trial participants to protect privacy.

To protect the privacy of trial participants before reusing or sharing trial data, trial sponsors anonymize the data. For example, as per Health Canada’s PRCI and EMA’s Policy 0070, trial sponsors must anonymize clinical study documents before publishing them on Health Canada or EMA data access portals.

Quantitative risk-based or statistical anonymization measures how easy it is to re-identify individuals through data such as medical event dates, medical history, and demographic information.

It then uses various data transformations, such as suppressing or removing outlier values in the data, generalizing demographic values or disease classifications, or shifting dates to reduce the likelihood of reidentification.

The continuous increase in data transformation reduces the identifiability of the information till it reaches a point below the applicable anonymization threshold. At this level, the data can no longer be identified.

This threshold is determined based on regulatory guidance, industry benchmarks, and data disclosure precedents. For example, both Health Canada and EMA recommend a threshold of 0.09. This is equivalent to having a minimum of 11 similarly looking individuals in every group based on the adopted and well-understood concept of k-anonymity and cell-size rules.

Role Of Anonymization Tech in Ensuring Data Privacy with Transparency and Public Disclosure

International regulatory standards like Health Canada and EMA 0070 have established specific guidelines to anonymize clinical data. This will help the pharma community further healthcare research by sharing trial data without compromising patient privacy.

Pharmaceutical companies need help to publish clinical documents on time and in an affordable fashion while protecting patient data privacy. It takes weeks or even months to anonymize unstructured data manually.

Worse, human intervention vastly increases the chances of error, leading to heavy fines and penalties resulting from the reidentification of patient information or data breaches.

Gramener’s AI-nonymize solution can boost a healthcare team’s efficiency, meet stringent regulatory policies and minimize reidentification risks. It has already helped clients save annual costs of up to $ 1 Mn and reduce turnaround time from a staggering 45 days to just seven days.

Conclusion

In this blog, we explored what data privacy and confidentiality means in healthcare and the laws governing them. We also discussed Health Canada and EMA 0070 in the context of transparency and privacy and how tech has the potential to transform anonymization in healthcare.

Stay tuned for the next blog in the series, where we will show how data privacy protection techniques can safeguard patient data. We will also discuss the different protection techniques and how AI and ML solutions can augment them.